Therapeutic-drug-monitoring-based ATG Targeted Dosing Strategy in Unmanipulated Haploidentical Haematopoietic Stem Cell Transplantation: a randomized, multicenter, phase 3 clinical trial.
Cancer LettJul 27, 2026 (epub)
Liping Dou, Nan Wang, Haoyang Zhang et al.
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In 30 seconds
This randomized, multicenter, phase 3 trial evaluated a therapeutic-drug-monitoring (TDM)-based dosing strategy for anti-thymocyte globulin (ATG) in haploidentical hematopoietic stem cell transplantation. Among 204 patients, the TDM group demonstrated a 365-day graft-versus-host disease-free and relapse-free survival (GRFS) of 66.7%, compared to 50.0% in the fixed dose group (HR, 0.666; P=0.048).
Key findings
- The TDM group had a 365-day GRFS of 66.7% versus 50.0% in the fixed dose group (P=0.048).
- Cumulative incidence of moderate to severe chronic GVHD was 9.8% in the TDM group compared to 22.5% in the fixed dose group (P=0.026).
- Fewer grade 3-5 infections occurred in the TDM group (44.1%) than in the fixed dose group (70.6%; P<0.001).
- Optimal ATG exposure was achieved in more patients in the TDM group (P=0.007).
Why it matters
The study highlights the importance of individualized dosing strategies in reducing the incidence of graft-versus-host disease and infections, potentially improving patient outcomes in hematopoietic stem cell transplantation.